1
Annexure II
DRAFT-II
GUIDELINES FOR RECOGNITION
OF
FOOD TESTING LABORATORIES
PREPARED BY
S.S. Marwaha, CEO
Ajit Dua, Senior Scientist
Punjab Biotechnology Incubator
SAS Nagar (Mohali)
Food Safety Standards Authority of India
FDA Bhawan near Bal Bhavan, Kotla Road,
New Delhi - 110002 India.
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CONTENTS
S.No.
1
2
3
4
5
6
7
8
9
10
11
12
13
I.
II.
III.
i.
ii.
iii.
iv.
v.
vi.
vii.
Title
Introduction
Scope
Criteria for recognition
Procedure for obtaining recognition
Surveillance
Extension of scope
Renewal of recognition
Terms and conditions of recognition
Expiry/ suspension and cancellation of recognition
Appeals against refusal / cancellation of recognition
Complaints
Schedule of fee
Relaxation in criteria
Annexures
Application For Laboratory Recognition / Renewal of Recognition
Product Categories for Scope-I & II
Format for Test Report
Appendices
Details of Technical Staff
Details of Authorized Signatories
Details of Authorized Sample Collecting Officers
Scope for Recognition
Details of Equipment
Details of Reference Material/Culture
Details of participation in International PT Programmes
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Page No.
3
3-5
6-7
7-13
13-14
14
14-15
15-20
20-21
21
22
22
22
23-26
31
32-34
27
27
28
28
29
29
30
1. Introduction
The Food Safety and Standards Authority of India (FSSAI) has
been established under Food Safety and Standards Act, 2006 which
consolidates various acts & orders that have hitherto handled food
related issues in various Ministries and Departments. FSSAI has been
created for laying down science based standards for articles of food
and to regulate their manufacture, storage, distribution, sale and import
to ensure availability of safe and wholesome food for human
consumption.
Ministry of Health & Family Welfare, Government of India is the
Administrative Ministry for the implementation of Food Safety and
Standards Act (FSSA). FSSAI has been mandated by the Food Safety
and Standards Act, 2006 for performing the various functions related to
Food Quality and Safety. These functions in addition to others include
“Laying down procedure and guidelines for accreditation of laboratories
and notification of the accredited laboratories”. Keeping this in view
these guidelines have been prepared for accreditation of laboratories
technically competent which are implementing Laboratory Quality
Management System as per International Standard ISO 17025.
2. SCOPE
This document lays down the guidelines for general as well as the
technical criteria for recognition, terms and conditions of recognition,
withdrawal / cancellation of recognition and financial aspects of the
Laboratory Recognition.
2.1. The recognition scheme is applicable to laboratories, which are
functioning independently irrespective of being an in-house
laboratory or linked directly or indirectly to any of the
manufacturing / processing unit /organization/ Institution to the
satisfaction of FSSAI provided the laboratory demonstrates that
there is no conflict of interest.
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2.2. Recognition shall be accorded to a laboratory for single
premises only where actual testing is carried out. If the
laboratory carries out testing activities in more than one
premises, separate recognition for each premise will have to be
obtained with a clear demarcation of scope of recognition.
However,
if
the
laboratory
establishes
field
/
satellite
laboratories for preliminary / screening tests near / at the place
of the primary production of the food, the facilities can be
considered as part of the central / main laboratory of the
establishment, with additional scope, where conformity tests
can be carried out for the presence of the particular
substance(s), provided such arrangements are addressed in
the Quality Manual of the Laboratory.
2.3. These criteria shall be applicable to Level 1- Food Laboratory,
Level 2- Food Laboratory and Referral Food Laboratory
which are defined below:
2.3.1. Level 1 Laboratory : The laboratory which is competent
to carry out the complete analysis as per “The Food
Safety and Standards (Food Products Standards and
Food Additives-Part-I & II) Regulations,2011”.
2.3.2. Level 2 Laboratory : The laboratory which is competent
to carry out the complete analysis as per “The Food
Safety and Standards (Food Products Standards and
Food Additives) Regulations, 2011” and “Food Safety and
Standards
(Contaminants,
Toxins
and
Residues)
Regulations,2011”.
2.3.3. Referral Food Laboratory: The Laboratory having
competence to carry out the analysis as per “The Food
Safety and Standards (Food Products Standards and
Food Additives) Regulations, 2011” and “Food Safety and
Standards
(Contaminants,
Regulations,2011”.
Toxins
and
Residues)
In addition the Referral laboratory
must have the competence to meet the following
requirements :
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2.3.3.1.
R & D Capabilities : For investigation for the
purpose of fixation of standard of any article of
food and standardizing methods of analysis. The
preference will be given to the Laboratories having
documentary evidence for carrying out R&D in
food sector.
2.3.3.2.
Training Facilities : The laboratory should have
training center for Capacity building by way of
organizing professional training, workshops and
seminars for the Food. The preference will be
given to the Laboratories having documentary
evidence for conducting trainings / workshops /
seminars in food sector.
2.3.3.3.
Other Facilities : The laboratory should have all
the other required facilities for performing the
functions of Referral Food Laboratory as defined in
the Act and reproduced below:
2.3.3.3.1. Analysis of samples of food sent by any officer
or authority authorized by the Food Authority
for the purpose and submission of the
certificate of analysis to the authorities
concerned;
2.3.3.3.2. Investigation for the purpose of fixation of
standard of any article of food;
2.3.3.3.3. Investigation in collaboration with the
laboratories of Food analysts in the various
States and such other laboratories and
institutions which the Food Authority may
approve on its behalf, for the purpose of
standardizing methods of analysis.
2.3.3.3.4. Ensuring that the laboratory follows the
scientific
protocols
laid
down
for
handling/testing the articles of food.
2.3.3.3.5. Maintaining high standards of accuracy,
reliability and credibility in the operation of the
laboratory and achieving and maintaining the
required levels of accreditation and reliability.
2.3.3.3.6. Laying down mechanism for ensuring that
personnel of the laboratory adhere to high
professional standards and discipline.
2.3.3.3.7. Such other conditions, as the Authority may
lay down for Referral Laboratories.
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3. CRITERIA FOR RECOGNITION
3.1. The laboratories seeking recognition shall have implemented
and maintained Quality Management System in accordance
with the latest version of ISO / IEC 17025 'General
requirements for the competence of Testing and Calibration
laboratories'. The applicant laboratory shall have adequate
capability and competence for testing of food safety and quality
parameters as per the requirements of Food Safety &
Standards Act 2006.
3.2. The applicant laboratory must be NABL accredited.
3.3. The Laboratory should have conducted at least one internal
quality system audit and one technical audit covering all areas
under the scope applied for.
3.4. The
Laboratory
should
have
conducted
at
least
one
management review meeting, before applying.
3.5. The Laboratory should have participated at least in one Inter
Laboratory Comparison / Proficiency Testing Programme for at
least one parameter in one matrix out of the scope applied for.
The Laboratories having participated in International PT
programme shall be preferred.
3.6. Personnel : The laboratory should have sufficient qualified,
trained and experienced staff to handle the testing jobs under
scope. Also the Laboratory should have trained Sample
Collecting Officers, if Sampling is under the scope applied for.
The laboratories recognized under scheme, shall have to have
at least one qualified Food Analyst (must have cleared food
analyst exam conducted by FSSAI), within a period of two (02)
years of the recognition of the Laboratories. The laboratories
already having qualified food analyst shall be given preference.
The qualifications and experience of the food analyst as
defined in the act are reproduced below:
3.6.1. Qualifications : A person shall not be qualified for
appointment as Food Analyst under the Act unless
she/he holds a Master’s degree in Chemistry or
Biochemistry or microbiology or Dairy Chemistry or Food
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Technology, Food and Nutrition or holds Bachelor of
Technology in Dairy/Oil or holds degree in Veterinary
Sciences from a university established in India by law or
is an associate of the Institution of Chemists (India) by
examination in the section of Food Analysts conducted by
the Institution of Chemists (India) or any other equivalent
qualification recognized and notified by the Central
government for such purposes and has not less than
three years experience in the analysis of food; and Has
been declared qualified for appointment as a Food
Analyst by a board appointed and notified by the
Authority. A person appointed as Food Analyst shall
undergo all specialized training programmes specified by
the Food Authority periodically.
3.6.2. Duties :The Food Analyst shall analyse or cause to be
analysed the article of food sent to him for analysis. In
analyzing the article of food, the Food Analyst shall follow
such instructions and shall adhere to such procedure as
adopted by the Food Authority from time to time. The
report of analysis shall be signed by the Food Analyst.
After completion of analysis of article of food, the Food
Analyst shall send his report to the Designated Officer, or
the Purchaser of article of food, as the case may be.
3.7. The Applicant Laboratory must have all the infrastructure and
facilities required for carrying out the analysis as per the scope
applied for.
3.8. Equipment : The Applicant Laboratory for recognition as Level1, Level-2 and Referral Laboratories should have all the
equipment
required
for
testing
under
their
scope
of
accreditation. In addition to the basic requirement, the Level 2
and Referral Laboratory must have at least one LCMSMS,
GCMSMS, AAS, HPLC, GC and ELISA Reader & Washer.
4. PROCEDURE FOR OBTAINING RECOGNITION
4.1. APPLICATION
4.1.1. Interested Laboratory shall apply to the FSSAI office in
duplicate in the prescribed proforma as per format at
Annexure-I along with copy of its Quality Manual and
application fee, as prescribed from time to time. The
application fee is non- refundable. The Schedule of Fee is
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given in Clause No. 10. Application fee shall be applicable
separately for each of the scope given below:

Scope 1 : Parameters covered under the Food
Safety and Standards (Food Products Standards and
Food Additives) Regulations, 2011 as updated on
FSSAI’s website from time to time.

Scope 2 : Parameters covered under the
Food
Safety and Standards (Contaminants, Toxins and
Residues) Regulations, 2011 as updated on FSSAI’s
website from time to time
The Product Categories for scope of recognition should
be defined under the titles given at Annexure-II:
4.1.2. The applicant laboratory shall ensure the following:
4.1.2.1.1.
The scope shall not be amended /changed;
however, it may be reduced, but, shall not
be appended, till on-site
assessment is
completed once application is submitted.
4.1.2.1.2.
The scope for recognition shall not include
any test by sub-contracting. Sub-contracting
is permitted with prior
permission
of
FSSAI / the customer from another FSSAI
recognized laboratory with valid scope of
recognition.
Sub-contracting
is
not
permitted from the laboratory, which is not
recognized by FSSAI.
4.1.3. The application shall be signed by the proprietor/partner
or the Managing Director/Chief Executive Officer (CEO)
of the laboratory or any other person duly authorized for
the purpose. The authorization shall be supported with
the Resolution or a letter, as applicable under companies
act/rules by Governing Council/ Governing Board/Board
of Directors of the company. The name and designation
of the person signing the application must be recorded
legibly in a space set apart for the purpose in the
application form.
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4.1.4. The laboratory shall have adequate infrastructure,
equipment facilities and resources to perform the tests
under the scope for recognition, which shall be verified
during the on-site assessment.
4.1.5. If necessary, FSSAI shall seek further information from
the applicant in order to facilitate processing of the
application.
4.1.6. FSSAI reserves the right to reject an application for one
or more of the following reasons:
4.1.6.1.
4.1.6.2.
4.1.6.3.
4.1.6.4.
4.1.6.5.
4.1.6.6.
4.1.6.7.
4.1.6.8.
The laboratory does not have adequate facilities
for the scope applied for as given in its application;
Application fee as applicable for each scope for
recognition and adequacy audit fee, as applicable
has not been submitted;
Application form is not completely filled;
Quality Manual has not been submitted along with
the application and not addressing the scope
applied for, adequately;
In case of renewal of recognition, performance of
the laboratory is not satisfactory during its earlier
recognition;
The laboratory is sub-contracting any test under
the scope for recognition.
The Laboratory not meeting any of the criteria for
recognition as per Clause-3.
FSSAI reserves the right to reject the application,
without giving any reason.
4.2. ADEQUACY AUDIT
After acceptance of the application, adequacy audit of the
Quality Management System shall be conducted by Assessor/
any other person deputed by FSSAI based on the Quality
Manual submitted by the laboratory. The laboratory shall pay
adequacy audit fee as per Clause No. 10. Any deficiencies
observed in the Quality Manual shall be communicated to the
applicant within 01 month of the receipt of Quality Manual in
FSSAI , for taking suitable corrective actions. The laboratory
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would resubmit the Quality Manual after review and revision
along with applicable adequacy audit fee for further adequacy
audit within 15 days of the dispatch of Non Conformances
(NCs) from FSSAI.
The adequacy audit of Quality Manual may not be carried out at
the time of renewal, in case it is not a new revised issue.
4.3. ASSESSMENT
4.3.1. FSSAI shall process the application for on-site
assessment only after adjudging the suitability of
management system by adequacy audit. A team of
assessors as per scope applied by the laboratory shall
be deputed by FSSAI to ascertain compliance to the
documented Quality Management System, equipment
facilities/ infrastructure and technical competence. The
laboratory shall make arrangements for travel and stay
of the assessors and provide the facilities required for
on-site assessment as per the auditing principles.
4.3.2. The on-site assessment shall have the following steps:
4.3.2.1.
4.3.2.2.
Opening Meeting - This meeting will be
conducted by the assessment team leader (Lead
Assessor) in which the Chief/Head of the
laboratory, the Quality Manager (QM) and the
technical heads of all the divisions being audited
are expected to be present. During this meeting,
the team leader will explain the scope and extent
of the assessment as well as the proposed plan for
assessment. The scope for recognition shall not
be changed during the opening meeting.
Permission to take photocopy or photograph of
documents relevant to substantiate the audit
findings shall be complied with by the laboratory.
The laboratory shall ensure that necessary
infrastructure facilities and documentary evidences
are provided promptly to complete the assessment
in scheduled time. The laboratory shall primarily
be responsible for completing the assessment in
scheduled time.
Conducting Assessment - The assessment shall
be conducted as per the assessment plan agreed
to during the opening meeting, and shall cover
areas of the relevance to the scope of recognition
of the laboratory. Evaluation shall include
verification of test facilities, accommodation and
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4.3.2.3.
environment, examination of documents and
records, assessment of competence of laboratory
personnel in conducting laboratory analysis/
testing, performance in witness tests, documentary
evidence
of
participation
in
International
Proficiency testing programs for relevant analytes
and matrices and compliance to its Annual Plan for
participation in such programs etc. A laboratory
official, conversant with the activities of the
division(s) being audited, should accompany each
assessor. The non-conformances (NCs) identified
by the assessment team shall be briefed and
submitted to the auditee for necessary corrective
action(s).
Closing meeting - The assessment shall
conclude with a closing meeting during which the
assessment team shall present its findings to the
laboratory. All the members present in the opening
meeting should preferably be present in the
closing meeting. The non-conformance reports
shall be acknowledged by QM or authorized
signatory, as a token of acceptance and time
frame for the corrective action(s) will be agreed to.
No NC shall be closed either during the
assessment or at the time of closing meeting.
4.4. The Assessment team shall recommend for recognition of the
laboratory for the specific scope in case there is no major or
minor NC.
4.4.1. Major NCs shall cover the following :
4.4.1.1.
Absence of a procedure required by ISO/IEC
17025
4.4.1.2.
Significant failure to implement a procedure
4.4.1.3.
Direct effect on the quality of test results.
4.4.2. All NCs other than listed at 4.5 qualify as minor NCs
4.5. The scope recommended shall not include the parameters that
are sub-contracted by the laboratory. The lead assessor and
the corresponding technical assessor shall duly sign on the
recommended scope with appropriate recommendations.
4.6. In case NC has been raised by the team of assessors, the
scope can be recommended subject to verification of the
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actions taken for closure of the NCs. Assessor shall not carry
out any verification of the closure of NC, raised during the
current assessment. No NC shall be closed at the end of the
assessment. The laboratory shall ensure the closure of NC(s)
within stipulated time period of not more than two months.
The minor NC closure may not require on-site verification.
However, closure of major NC may require on-site verification.
In case of non-closure of the NCs within the stipulated time
period, the laboratory shall have to apply a fresh after satisfying
itself about the closure of the NCs and ensuring compliance to
the requirements.
4.7. The Lead Assessor shall send Assessment Report to FSSAI
within five (05) days after completion of the assessment of the
laboratory.
4.8. ASSESSMENT FEE
The applicant laboratory shall bear assessment fee, as
estimated by FSSAI, for the number of assessors and mandays deputed for assessment, based on the scope applied for
and arrangement for travel/stay etc. as per Clause No. 10.
4.9. RESPONSIBILITIES
OF
APPLICANT
DURING
THE
ASSESSMENT
The laboratory is expected to provide the following assistance
to the assessment team during the visit:
4.9.1. Arrangements for stay, local guidance, travel etc.
4.9.2. A representative of laboratory to accompany the team
during the assessment.
4.9.3. A suitable room where members of the team can meet
and discuss during the day and at the end of the day to
exchange their notes and findings.
4.9.4. Secretarial and other office assistance like photocopying,
etc.
4.9.5. Free accessibility to the records, test facilities as is
deemed relevant by the assessors
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4.10.
ON-SITE VERIFICATION ASSESSMENT
The laboratory shall take necessary corrective actions
within the stipulated time period of not more than two
months for the closure of the NC’s, brought on record by
the assessment team, which will have to be verified by
the corresponding assessor before considering it for
grant of recognition. On-site verification assessment by
the corresponding assessor may be required for closure
of major NCs. This follow up visit, for full or partial
assessment, may be carried out as above. The applicant
Laboratory shall make all the arrangements as per
Clause No. 4.8 and bear the assessment fee.
4.11.
GRANT OF RECOGNITION
4.11.1.
4.11.2.
Based on the recommendation of the assessment
team, FSSAI shall consider for grant of recognition to
the laboratory. The laboratory will be issued a
Certificate of recognition annexed with the scope of
recognition. The decision of the FSSAI for granting
the recognition or otherwise shall be final.
The recognition granted shall be valid for a
period of three (03) years from the date of
recognition. The renewal of recognition shall also be
for three (03) years at a time. It shall be binding for
the recognized laboratory to comply with the
directions/any modification in the scheme, issued by
FSSAI from time to time. The FSSAI recognized
laboratory shall bound with the terms and conditions
given under Clause No. 8.
4.12. CONSIDERATION FOR NABL ACCREDITATION
Laboratories having NABL accreditation shall be given due
weightage depending upon the scope of accreditation but not
binding to FSSAI for consideration.
5. SURVEILLANCE
5.1. The recognized laboratory shall be subjected to surveillance
audit at the end of the 1st year of recognition to verify the
continued compliance and maintenance of competency and the
implementation of quality system established by the laboratory.
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The laboratory shall be subjected to verification audit in case of
any complaints in sampling, testing and test reports or any
other reasons.
5.2. During the validity of recognition, if the laboratory is found
violating the terms and conditions of recognition, its recognition
is liable to be suspended and may call for verification visits, for
which the laboratory is liable to pay visit charges, as set out in
Schedule of Fee given in Clause No. 10.
6. EXTENSION OF SCOPE
The recognized laboratory can request for extension of its
scope of recognition to cover additional products/matrices and
test parameters of the interest to FSSAI by following the
procedure as given in Clause No.4. The laboratory shall apply
in the prescribed format by filling in the relevant information
applicable to the extension of scope along with supporting
documents and application fee prescribed in Clause No. 10. In
case the Quality Manual is revised, Current Quality Manual
shall also be submitted for scrutiny along with adequacy audit
fee prescribed in Clause No. 10. On-site assessment shall be
conducted for the applied scope for extension as per the
procedure given in Clause No. 4. Assessment fee shall be
applicable as per Clause No. 10.
7. RENEWAL OF RECOGNITION
7.1. Any recognition granted automatically expires at the end of the
period of its recognition. The recognized laboratory shall apply
to FSSAI at least six months before the date of expiry of its
recognition. Application for renewal of recognition shall be
rejected if application does not reach to FSSAI before six
months of expiry of its current recognition.
7.2. The laboratory shall submit the application for renewal of its
recognition as per Clause No. 4. Assessment for renewal of
recognition shall be carried out similar to the initial assessment.
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7.3. It shall be ensured during renewal assessment that the terms
and conditions for recognition were not breached during the
validity of recognition.
7.4. In case there is a impediment in renewal of recognition, the
laboratory shall undertake to maintain the integrity of already
received samples by providing appropriate storage conditions
and return to the client in its original condition so that the same
can be analyzed in another laboratory. No test report shall be
issued by the laboratory when it has no valid recognition of
FSSAI. The laboratory shall restrict itself from entertaining any
sampling and/or testing for the commodities or product within
the purview of FSSAI, 2006, when it has no valid recognition of
FSSAI.
8. TERMS AND CONDITIONS OF RECOGNITION
8.1. The recognition shall be granted for a period of three (03)
years, which shall be renewable for maximum period of three
years at a time subject to satisfactory performance based on
periodic review/ surveillance and assessment for renewal of the
laboratory by FSSAI. The laboratory shall apply for its renewal
at least six months before expiry of recognition.
8.2. The recognized laboratory shall perform all the tests in its
approved premises as per the valid scope of recognition. Subcontracting is permitted with prior permission of FSSAI / the
customer in another FSSAI recognized laboratory with valid
scope of recognition. Sub-contracting is not permitted from the
laboratory, which is not recognized by FSSAI.
8.3. The recognized laboratory shall not make any change in the
Quality Management System, which forms the basis for the
grant of the recognition and which prevents its compliance to
the Scheme without prior recognition of FSSAI. It shall
document all changes made to the Quality Management
System and make records of such changes available to FSSAI
within a period of 15 days of making the changes.
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8.4. Any change in key personnel in relation to quality assurance,
key technical functions or senior management shall be duly
intimated to FSSAI within a period of 15 days.
8.5. The recognized laboratory shall inform FSSAI, immediately
about the major changes/breakdown of equipment with reasons
thereof
etc.
effecting
testing
of
the
relevant
products/compliance to this laboratory scheme. The laboratory
shall not carry out sampling or accept any sample for testing,
when there is breakdown of the equipment to be required for
performing the test(s). The laboratory shall not carry out
sampling or accept any sample for testing, without prior
recognition of FSSAI, when there is major change in the Quality
Management System, which may affect performance of the
testing.
8.6. The recognized laboratory shall inform FSSAI within 5 working
days about the suspension / withdrawal of accreditation from
NABL.
8.7. Testing of Samples : The following instructions shall be
followed by the recognized laboratory for testing the samples
sent by FSSAI or Food Business Operator or consumer for the
purpose of monitoring / certification:
8.7.1. Sample shall always be accompanied by a test request
specifying the parameters and purpose.
8.7.2. Whenever required, the recognized laboratory shall draw
samples only by its own trained Sample Collecting
Officers.
8.7.2.1. The Sample Collecting Officer shall strictly adhere
to the sampling procedure and provide sampling
details as per FSSAI requirements. The sample
shall be drawn only from the complete Assortment
/ Batch / Lot as the case may be having uniform
characteristic in the form of source / production
conditions / processing conditions.
8.7.2.2. The Sample Collecting Officer shall also ensure
drawl of true representative sample of complete
Assortment/ Batch/ Lot as the case may be.
8.7.3. The laboratory shall ensure, while accepting the samples
/ sample containers sealed by Food Safety Inspector /
authorized representatives of laboratory, that the seal is
17
intact with the details of the sealing indicated in the test
request. A statement / record to this effect shall be made
on receipt of sample and in the test report by the
concerned laboratory.
8.7.4. The laboratory is liable to maintain confidentiality of
samples and information thereof.
8.7.5. Test Methods : The Manual of the Methods of Analysis
(FSSAI Manual), as amended/adopted by FSSAI from
time
to
time
including
AOAC
/ISO
/Pearsons
/Jacob/IUPAC/Food Chemicals Codex /BIS /Woodmen
/Winton-Winton /Joslyn shall be used for analyzing the
samples of food articles. However, in case the method for
analyzing any parameter is not available in these
manuals, a validated method of analysis prescribed by
Internationally recognized Analytical/Regulatory agencies
, shall be adopted.
8.7.6. Test Report : The test report duly sealed in confidential
cover unless the report is sought by any other means in
the format as per Form A (for Level-I & Level II
Laboratories) / Form B
(For Referral Laboratories) of
FSSA (Annexure-III A & B) shall be sent to the officer /
Food Business Operator/Consumer, who has sent the
sample and requested the testing.
8.7.6.1.
8.7.6.2.
8.7.6.3.
The test report shall clearly indicate who has
drawn the sample and the reference method.
The laboratory shall issue the test reports
immediately after completion of the tests and not
later than a maximum period of 14 days from the
date of receipt of sample or as defined by FSSAI
from time to time.
The
Test
report/Certificate
shall
include
information as per the details given in Form A/
Form B of FSSA. Additionally the information shall
be in compliance with the ISO/IEC 17025
requirements.
8.7.7. Sample Retention : The laboratory shall keep the
remnants of the sample after testing for a minimum
18
period of one month except for perishable items, under
stipulated storage conditions as given in Test Request by
the customer or as deemed fit by the laboratory before
they are disposed off or returned to the customer.
8.7.8. The test report shall be treated as strictly confidential
between
the
testing
laboratory
and
FSSAI.
No
information regarding the sample or its results shall be
divulged to any person including the FBO who may
deliver the sample for testing on behalf of FSSAI.
However,
in
case
sample
is
submitted
by
the
FBO/Consumer for testing within the scope of recognition
for the purpose of self monitoring or for monitoring /
certification by FSSAI, the details of testing shall be made
available to FSSAI.
8.7.9. The FBO shall not be allowed to witness the test or to
come in contact with the testing personnel without prior
recognition of FSSAI. Any assistance or intervention
required from the FBO for testing the sample shall be
duly indicated by FSSAI in the test request and shall be
reported in the test report.
8.7.10. Record Retention : The laboratory shall maintain the
record of observations and a copy of the test report for a
minimum period of three years.
8.7.10.1. In case of withdrawal / cancellation of recognition,
the laboratory shall give an undertaking to make
available of the records of FSSAI related testing of
three years.
8.7.11. The
recognized
laboratory
shall
participate
in
Proficiency Testing / Inter-Laboratory Test Comparison
programmes organized by national and international
bodies
of
repute
for
demonstrating
technical
competence of the laboratory personnel, at its own
cost.
19
8.8.
The recognized laboratory shall permit access to FSSAI
officer(s)/team(s)
deputed
for
the
purposes
of
assessment, surveillance or investigation. It shall give
access
to
all
relevant
records,
documents
and
equipments etc. for the purpose of verifying any details.
8.9.
An recognized testing laboratory shall not use its
recognition in such a manner as to bring FSSAI into
disrepute/dispute and shall not make any statement
relevant to its recognition, which FSSAI may consider to
be misleading.
8.9.1.
8.9.2.
The recognized laboratory may make a public
claim regarding its recognition. However, such
claim shall be strictly based on the scope of its
recognition. It shall discontinue claiming FSSAI
recognition and withdraw all promotional and
advertising material upon expiry / suspension or
cancellation of its recognition.
The recognized laboratory shall furnish either a
Performance Bank Guarantee (PBG) of `One Lakh
or the payment of ` One Lakh (refundable) by way
of Demand Draft/ Pay order drawn in favor of
FSSAI before grant of recognition. This guarantee/
payment made can be invoked only with the due
recognition of the Chief Executive Officer FSSAI,
by his nominated official for breach of any of the
terms & conditions of FSSAI. The referral
laboratory need not submit any PBG. The PBG
shall be forfeited under following circumstances :
8.9.2.1.
8.9.2.2.
8.9.3.
8.10.
If the laboratory is found violating the terms
and conditions of recognition.
If the laboratory is found indulging in
unethical practices
The laboratory shall be issued a show cause for
time bound reply and reasons furnished thereof
shall be adjudged by the nominated official of
FSSAI before any action for invocation of its bank
guarantee/ payment is initiated
A laboratory may relinquish recognition by giving three
months notice in writing to FSSAI. It shall however either
complete testing of all samples pending with it or return
20
the pending samples along with the test requests. It shall
not be entitled to any refund of recognition fee.
8.11.
FSSAI
may
at
its
discretion
cancel
or
suspend
recognition, reduce the scope or direct reassessment due
to changes in personnel/equipment, break-down of
equipment, and/or if a complaint or any other information
is received which indicates and is proved that the
technical competence and integrity/ confidentiality of the
laboratory is not satisfactory.
8.12.
The
laboratory
shall
not
use
the
recognition
certificate/letter after its validity period is over or in case
of cancellation of recognition.
8.13.
The recognized laboratory shall not handle any sample of
the client for testing when the laboratory fails to
demonstrate satisfactorily to FSSAI that its direct/indirect
trade association has no consequence/ bearance on its
test results.
8.14.
The recognized laboratory shall submit the following
statements at the end of every financial year after
recognition of the laboratory by FSSAI.
8.14.1.
Number of samples received for testing and
number ofsamples tested
8.14.2.
Number of samples failed specifying
parameter/test
and other details
the
9. EXPIRY/SUSPENSION AND CANCELLATION OF RECOGNITION
9.1. The recognition of laboratories shall automatically expire at the
end of their validity, unless renewal is sought timely by the
concerned laboratory along with the prescribed fee.
9.2. The recognition of laboratories shall also expire if the renewal is
not agreed to by FSSAI without giving any reason.
9.3. The recognition of laboratories may also be suspended /
cancelled any time during the recognition period for any and or
the reasons given below:
21
9.3.1. If FSSAI feels that no useful purpose is being
served by the
continuation of the recognition of
the laboratory.
9.3.2. If the laboratory is found violating the terms and
conditions of recognition.
9.3.3. If the laboratory is unable to maintain the Criteria
for Recognition.
9.3.4. NABL suspends accreditation
9.3.5. If the laboratory is found indulging in unethical
practices
9.4. FSSAI shall issue a show cause notice in case it intends to
suspend / cancel recognition of a laboratory, as per clause 8.9
after due investigation, if required. The concerned laboratory
shall be given an opportunity to explain its view point before
any action is taken against the laboratory.
9.5. The laboratory may apply afresh not earlier than one year from
the date of cancellation / withdrawal / non-renewal of
recognition.
9.6. The
laboratory
shall
return
the
pending
sample(s)
in
appropriate conditions to the customer for onward transmission
to another recognized laboratory and undertake to retain
records as per requirements of Clause 8.10.1 on cancellation /
withdrawal / non-renewal / expiry of recognition.
10. APPEALS AGAINST
RECOGNITION
REFUSAL
/
CANCELLATION
OF
The Laboratories can appeal to FSSAI in case of refusal to grant
and cancellation of existing recognition
10.1.
10.2.
In case of appeal against refusal recognition, FSSAI will
consider the application on merit basis and in case found
necessary may order re-assessment of the laboratory,
during which time the NCs pointed out by the assessment
team should be rectified by the laboratory.
In case of appeal against the cancellation of recognition,
the original certificate for the award of recognition must
be submitted alongwith the appeal.
22
11. COMPLAINTS
Any complaints received regarding laboratory recognition shall be
handled as per complaint handling procedure of FSSAI
12. SCHEDULE OF FEE
12.1.
The following shall be the fee payable by applicant/
recognized laboratory.
Sr.
No.
1.
Purpose
Fee (Rs.)
Application Fee: (Recognition / renewal 50,000/- per scope
of recognition for each scope) for each
as specified under Clause No. 4.1.1
Assessment Fee / Surveillance Fee / 5000/- per man-day plus expenses
Special visit charges
for travel and stay of assessors at
actual
Recognition Fee (to be paid in advance 50,000/on consideration for recognition)
Enhancement of Scope (for each as 10,000/- per scope + Assessment
specified under Clause No. 4.1.1)
Fee as defined at Sr. No. 3 above
2.
3.
4.
12.2.
The laboratory shall make these payments in the form of
Demand Draft / Pay Order drawn in favor of Food Safety
& Standards Authority of India, payable at Delhi
13. RELAXATION IN CRITERIA
13.1.1.
13.1.2.
In case of need for specialized laboratory, the
compliance to Criteria for Recognition as per Clause
No. 3 may be relaxed at the discretion of FSSAI and
laboratory may be recognized based on technical
competence only.
Anything not covered under this recognition scheme
shall be dealt on case to case basis under the
provisions of FSSAI rules & regulations in force.
23
Annexure-I
APPLICATION FOR LABORATORY RECOGNITION / RENEWAL OF
RECOGNITION
(Under the FSSAI Laboratory Recognition Scheme)
A)
Type of Laboratory (please tick)
Level 1 / Level 2 /
Referral Lab
Type of Recognition (Please tick)
Fresh / Renewal
Laboratory Details
1.
Name of the Applicant Laboratory
2.
Address of location for which recognition
is sought?
3.
Phone, Fax and e- mail
4.
Address of Head office (if different from 2.)
5.
Phone, Fax and e- mail
6.
Type of Organization (Govt./Semi
Govt./Private/Educational
Institution/Other)
7.
Legal status and date of establishment
(Please give registration number and
name of the authority who granted the
registration with all documentary proof)
Attach documentary Proof.
9.
Laboratory Premises/Layout
Total space available (Sq Feet)
9.1
Layout plan of the laboratory indicating
9.2
10.
testing areas, seating plans, receipt and
storage of samples, administration and
other facilities(Attach Layout Plan )
Other Accreditations / Recognitions /
Approvals
(Attach List )
24
B)
Organisation
11.
Manpower details
12.
Name and designation of the person
responsible for technical operation/
Technical Manager(s).
13.
Name and designation of the person
responsible for Quality Management
Systems/ Quality Manager.
14.
Total No. of personnel
15.
Senior management (No.)
16.
Testing personnel (No.)
17.
Details of professionally qualified staff with
qualification (Enclose details as per format
given at Appendix I)
18.
Authorized signatories for issuance of test
reports (enclose details as per format
given at Appendix II)
19
Authorized Sample Collecting Officers
(enclose details as per format given at
Appendix III)
C)
Technical information
20.
Scope for recognition proposed (in case
of Fresh Recognition) or Recognized
scope by FSSAI (in case of renewal of
recognition). (Please attach in the format
as per Appendix IV)
21
Date of validity of recognition (in case of
renewal of recognition)
22.
Has the laboratory implemented Quality
Management System (QMS) as per
guidelines of ISO/IEC 17025: latest
version?
23.
Does the QMS cover the scope for
recognition as required by FSSAI
24.
Whether accredited by NABL as per
ISO/IEC 17025 latest version?
24.1
If yes, does the scope of accreditation
cover the scope applied for FSSAI
25
recognition ? (please attach certificate
and scope of accreditation along with a
separate comparison sheet at)
16.
List of equipment with laboratory (Attach
at Appendix V in the format given)
17.
List of Standard/ Certified reference
materials (SRM/CRM) available for use:
(Attach at Appendix VI in the format
given)
18.
Internal Audit and Management Review:
18.1
Date of last Internal Audit, its findings and
corrective actions taken (Attach copies)
18.2
Whether all requirements of ISO/ IEC
17025: 2005 covering all activities of
laboratory have been audited at least
once in last one year
18.3
Date of last Management review (Attach
copy of Agenda and Minutes of
Management Review)
20.
Details of subcontracting, if any
21.
Proficiency Testing: Participation in
International and National PT programme
: (Attach details as per format at
Appendix VII)
22.
Total Turnover (in terms of Test reports
issued for last 3 years as per the scope)
22.1
For domestic purposes
22.2
For imported Samples, if any.
24.
Any complaints/disputes in last three
years pertaining to laboratory testing
activities (Please attach details)
D)
Details of Fee:
25.
Fee in the form of Demand Draft / Pay
Order payable to FSSAI (No and Date)
25.1
Application Fee
25.2
Adequacy Audit Fee `
E).
Declaration By The Laboratory:
I / We declare that
26
a)
b)
c)
d)
e)
f)
g)
We have read & understood the terms and conditions of the
FSSAI Laboratory Recognition Scheme and are willing to
abide by them
We agree to comply fully with ISO/IEC 17025: latest version for
the recognition of testing laboratory.
We agree to comply with recognition procedures, pay all costs
for assessment, verification visit (if any), surveillance and
reassessment irrespective of the result.
We agree to co-operate with the assessment team appointed
by FSSAI for examination of all relevant documents by them
and their visits to those parts of the laboratory that are part of
the scope of recognition.
We satisfy all national, regional and local regulatory
requirements for operating a laboratory.
In case of breach of any of the terms and conditions of FSSAI
Laboratory recognition scheme, the decision to invoke action/
Bank guarantee/ payment made, by FSSAI is final and binding
on us.
All information provided in this application is true to the best of
our knowledge.
Date:
Signature of Authorized Signatory
Place:
Name
Designation
Stamp
27
Appendix I
Details of Technical Staff
S.No
.
Name
Designation
Academic and
Professional
Qualifications
Relevant
Trainings
Experience
related to
present work
(in years)
Appendix II
Details of Authorized Signatories
S.
No
Laboratory/
Name &
Qualificati Experience in Relevant Authorized Specimen
Department/ Designation
on with years related Training for which Signature
Specializa
to present
specific
Section
of Signatory
area of
tion
work
testing
28
Appendix III
Details of Authorized Sample Collecting Officers
S. No
Name
Designation
Academic and
Professional
Qualifications
*
Experience related to
present work (in
years)
Appendix IV
Scope for Recognition
Sl no
Group of products,
Specific tests or
materials or items tested types of tests
performed
Note 1.
Specification,
Range of
standard (method) or testing/ Limit of
technique used
detection
Laboratories performing site testing shall clearly identify
the specific tests on product(s)/ material performed at
permanent laboratory and/ or at site.
29
MU
( )
Appendix V
Details of Equipment
S.No. Name of
equipment
Make/Mo Receipt date Range
del/ year & date placed and
of make in service
accurac
y
Purpose /
scope of
the
equipmen
t
Maintena
nce (In
house/
outside)
Date of
Calibration Calibrat
last
due on *
ed by**
calibratio
n
Appendix VI
Details of Reference Material/Culture
S.No.
Name of reference
material/
strain/ culture
Source
Date of expiry/
validity
Traceabili
ty
30
Appendix VII
Details of participation in International PT Programmes
Sl.
no.
Product/
Material
Details of
Test(s)
Date of
Testing
Nodal
Performance Corrective
in terms of action taken
Laboratory
Z score
(Accreditation
body/
Country)
31
Annexure II
Product Categories for Scope I & II
Scope I
Dairy Products And Analogues
Cereal & Cereal Products
Fats, Oils And Fat Emulsions
Fruits & Vegetable Products
Sweets & Confectionery
Meat & Meat Products
Fish & Fish Products
Other Food Product and
Ingredients
Sweetening Agents including
Honey
Salt, spices, Condiments &
Related Products
Beverages,(Other than Dairy &
Fruits & Vegetables based)
Proprietary Food
Irradiation Of Food
Food Additives
Scope II
Metal Contaminants
Pesticide Residues
ANTIBIOTIC AND OTHER PHARMA-COLOGICALLY ACTIVE
SUBSTANCES
Crop contaminants and naturally occurring toxic substances
32
Annexure III A
FORM A
(Refer regulation 2.2.2)
CERTIFICATE OF ANALYSIS BY THE REFERRAL FOOD
LABORATORY
Certificate No. …………………….
Certificate that the sample , bearing number ……..purporting to be a
sample/of ……….. was received on ………….. with Memorandum No. …….
Dated ………….. From ……… [Name of the Court] ………… for analysis. The
condition of seals on the container and the outer covering on the receipt was
as follows: ………………………………………………………………………..
………………………………………………………………………..
I …………….. (name of the Director)_ …………….. found the sample to be
……………….. (Category of food sample) ……………… falling under
Regulation No. ……….. of Food Safety and Standards(Food Products and
Food Additive) Regulations, 2011. The sample was in a condition fit for
analysis and has been analyzed on ………….. (Give date of starting and
completion of analysis)……………… and the result of its analysis is given
below /*was not in a condition fit for analysis for the reasons given below:—
Reason:—
……………………………………………………………………………
Analysis Report:—
(i) Sample Description:—
………………………………………………………………………………
(ii) Physical Appearance :—
…………………………………………………………………………….
(iii) Label:— …………………………………………………………………………
Sl.No. Quality
Name of the Results
Prescribed Standards as per:Characteristics
Method of
the test used
(a) As per Food Safety and
Standards (Food Products and
Food Additive) Regulations, 2011
(b) As per label declaration or
proprietary foods
(c) As per the provisions of the Act
and Regulations, for both above
Opinion **
Place:
Date:
(Signature)
Director Referral Food Laboratory
(Seal)
* Strike out whichever is not applicable
** When opinion and interpretation are included, document the basis upon
which the opinions/interpretations have been made.
33
Annexure III B
Format for Test Report
FORM B
Report of the Food Analyst
(Refer Regulation (ii) of 2.3.1)
Report No._______.
Certified that I ___________ (name of the Food Analyst) duly
appointed under the provisions of Food Safety and Standards Act,
2006 (34 of 2006), for _____ (name of the local area) received from
_______* a sample of ____, bearing Code number and Serial Number
_____ of Designated Officer of _____ area* on_________(date of
receipt of sample)
for analysis.
The condition of seals on the container and the outer covering
on receipt was as follows:
____________________________________________
I found the sample to be …….. (category of the sample) falling under
Regulation No.____ of Food Safety and Standards (Food Products and
Food additive )Regulations, 2011. The sample **was in a condition fit
for analysis and has been analysed on _____ (give date of starting and
completion of analysis) and the result of its analysis is given below/
** was not in a condition fit for analysis for the reason given below:
Reasons:
………………………………………………............................
...........................................
Analysis report
(i) Sample Description
……………………………….
(ii) Physical Appearance
……………………………….
(iii) Label
……………………………….
S.No.
Quality
Characteristics
Name of
the
Method of
the test
used
Results
Prescribed Standards as per
(a) Food Safety and
Standards (Food
Products and Food
additive ) Regulations,
2011
(b) As per label
declaration for
proprietary food
(c) As per provisions of
the Act , rules and
regulations for both the
above.
34
Opinion***
Signed this _____ day of ______ 20
Analyst.
(Sd/-) Food
Address: * Give the details of the senders
** Strike out whichever is not applicable
*** When opinion and interpretation are included, document the basis
upon which the opinions/interpretations have
been made.
35